Study Evaluating Genotypes Using Lucentis (SEAGUL)

February 10, 2015 updated by: Paul S. Bernstein, University of Utah

VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis

The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Treatment naive exudative AMD patients will receive Lucentis treatment as standard of care, and followed monthly for 12 months. Standard ophthalmologic exams will be performed, along with ETDRS visual acuity and optical coherence tomography (OCT). A blood sample will be obtained for DNA analysis. The primary outcome measure is change in visual acuity at 4 months after initial Lucentis treatment. Secondary outcomes are change in visual acuity and retinal thickness at 12 months.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants
    • Colorado
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah, Moran Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Moran Eye Center Clinic

Description

Inclusion Criteria:

  • Treatment naive AMD patients;
  • At least 50 years of age;
  • Visual acuity between 20/40 and 20/320

Exclusion Criteria:

  • Pregnancy;
  • Prior enrollment in a ranibizumab clinical trial;
  • Previous therapy in either eye for AMD;
  • Concurrent eye disease that could compromise visual acuity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Active approved treatment
Drug: Lucentis
0.05 mg intravitreal injection
Other Names:
  • ranibizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Paul Bernstein, MD, PhD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 15, 2007

First Submitted That Met QC Criteria

May 16, 2007

First Posted (Estimate)

May 17, 2007

Study Record Updates

Last Update Posted (Estimate)

February 11, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21441
  • SEAGUL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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